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Violations Are Cited in Generics

As American consumers increasingly turn to generic drugs as a way to reduce their medical costs, the continued manufacturing problems of one generic maker stand out.

That company, the Indian drug maker Ranbaxy Laboratories, has run afoul of the Food and Drug Administration over the last two years for manufacturing violations at two of its plants in India. But now the company is under the spotlight for significant violations at a factory in the United States: Ohm Laboratories in Gloversville, N.Y., a Ranbaxy-owned plant that makes oral medications.

Ohm failed to properly investigate quality-control problems at the plant, including black particles found in a bottle of metformin oral solution, a diabetes drug, and floating cardboard particles found in batches of ranitidine solution, an ulcer drug, according to a report the F.D.A. posted on its Web site Thursday.

The Gloversville plant also failed to test an adequate number of each drug product, failed to train employees in certain procedures required by good manufacturing regulations, and failed to notify regulators of product problems in a timely fashion, the inspection report said.

“There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, purity they purport or are represented to possess,” regulators wrote in the report.

Federal inspectors had cited Ohm for violations found at the Gloversville plant last summer. But the report was not released until Thursday’s posting on the F.D.A.’s Web site, after The New York Times filed a document request under the Freedom of Information Act. Responding to a reporter’s query on Thursday, a Ranbaxy spokesman, Krishnan Ramalingam, e-mailed a news release that the company had issued last December.

The release said the company had retained a consulting firm to advise it on issues cited by the F.D.A. at the Ohm plant. It also said that Ohm Laboratories operated two plants other than the Gloversville facility and that those made most of the products the company supplied in the United States.

Although Ranbaxy is a relatively small player in the United States generic market, it nonetheless accounted for 29 million prescriptions in this country last year, according to IMS Health, an industry research company.

The F.D.A. has periodically cited generic and name-brand drug makers for manufacturing or quality-control issues. That includes a warning letter sent earlier this year to McNeil Consumer Healthcare, a unit of Johnson & Johnson, for failure to adequately investigate and notify regulators about consumer complaints of a moldy smell emanating from some Tylenol bottles. McNeil has recalled some lots of Tylenol and other over-the-counter products.

Photo

A scientist at a Ranbaxy research center in Gurgaon, India. One of the firm's American plants has been cited for quality control and other violations.Credit
Scott Eells/Bloomberg News

Gary J. Buehler, the director of the F.D.A.’s office of generic drugs, said in a phone interview Friday that the agency’s review, approval and inspection processes ensured that generics available in the United States were of high quality. Consumers, he said, should not judge the entire industry by agency actions taken against one company.

“Would the action against Johnson & Johnson give you pause to question Pfizer or Merck’s quality?” Mr. Buehler said. “Each generic company is separate and, just because one had a recall, it doesn’t mean they are all bad or that they have all fallen into an abyss.”

In 2008, the F.D.A. cited Ranbaxy for manufacturing violations at two of its facilities — in Dewas and Paonta Sahib, India. The agency also barred the import into the United States of more than 30 drug products made at those sites. And last year, after federal regulators determined that one of the plants falsified data and test results, the agency stopped reviewing new or pending drug approval applications from that plant, pending corrective action by Ranbaxy.

Deborah M. Autor, the director of compliance for the F.D.A.’s center for drug evaluation and research, said on Friday that the agency was troubled by Ranbaxy’s overall record of manufacturing and data integrity problems.

“We will continue to focus on this company until we are fully satisfied with the quality of its drugs and the integrity of its data,” Ms. Autor said in an e-mail message sent in response to a reporter’s query. “Companies have a responsibility to patients to ensure that their drugs are safe, effective and high quality."

Ranbaxy is not alone among generic drug makers subjected to federal scrutiny.

In a presentation at the generics conference last month, Randall Stanicky, a vice president of global investment research at Goldman Sachs, noted that the agency had cited a handful of smaller generic makers in 2008 and 2009 for manufacturing and quality-control violations. As a result of such problems among a few smaller generic makers, he said, larger generic makers have gained market share in the United States.

Ranbaxy’s small share of the United States market has declined as its manufacturing problems have mounted. Its 29 million prescriptions last year, representing 1.1 percent of the market in the United States, were down 41 percent from the previous year, IMS said.

Marah Binder, a spokeswoman for Daiichi Sankyo, a Japanese drug maker that bought a controlling interest in Ranbaxy in 2008, said on Friday that the Japanese company took manufacturing quality seriously and was committed to working with the F.D.A. to resolve any outstanding issues.

Daiichi Sankyo and Ranbaxy executives have put together a joint task force to make sure quality-control systems are in place and will improve, she said.

A version of this article appears in print on March 13, 2010, on page B1 of the New York edition with the headline: Violations Are Cited In Generics. Order Reprints|Today's Paper|Subscribe